ImThera Gets FDA Nod for Sleep Apnea Device Trial

The FDA has given ImThera Medical the go-ahead to begin a clinical study of its aura 6000 obstructive sleep apnea treatment device. The system is designed for patients who are unable or unwilling to try positive airway pressure therapy or other OSA interventions.

The San Diego, Calif., devicemaker is currently enrolling patients for the randomized, controlled Targeted Hypoglossal Neurostimulation, or THN3, Study at U.S. and European sites. The safety and efficacy data will be used to support a PMA application for the aura6000, ImThera said.

The aura6000 employs the company’s exclusive THN sleep therapy technology, which delivers neurostimulation to the hypoglossal nerve. The pulses increase muscle tone in the tongue, helping to prevent the tongue from collapsing into the upper airway during sleep and blocking respiration. “Essentially, the system keeps the tongue in an awake position while the patient sleeps,” explains study investigator Michael Friedman.

The system includes a small rechargeable pulse generator, which is implanted under the skin near the collarbone, and a multi-electrode lead situated in the upper neck.

The aura6000 is already available in Europe and other markets that observe the CE mark. — Kellen Owings

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.